DRG International, Inc. Total Thyroxine (T4) ELISA; REF EIA-1781 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Total Thyroxine (T4) ELISA; REF EIA-1781
Brand
DRG International, Inc.
Lot Codes / Batch Numbers
lot#: RN-60923 expiration date 12/31/2021, RN-60831 expiration date 12/31/2021
Products Sold
lot#: RN-60923 expiration date 12/31/2021; RN-60831 expiration date 12/31/2021
DRG International, Inc. is recalling Total Thyroxine (T4) ELISA; REF EIA-1781 due to Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagn. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples.
Recommended Action
Per FDA guidance
On 10/18/2021, DRG issued Medical Device Recall Notification letters and response forms to the End-user through confirmation of the Distributor. All customers were notified via e-mail. Actions Required: 1) Please immediately discontinue use or distribution of the affected lots. 2) If you have further distributed the affected product lots, please identify and immediately notify those customers at once of this product recall by providing a copy of the recall notice and response form. 3) If you have relabeled or rebranded the affected product lots, please follow your internal recall process and notify the appropriate regulatory bodies as required. 4) Disposal of all affected lots should be in accordance with applicable national, st ate, and local laws and regulations. 5) Complete and return the response form.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, DE, NY
Page updated: Jan 10, 2026